BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Clear Rayz for Him Stormy

    DI: 00851478007196 · Model: DPA-021-Stormy · QUASAR BIO-TECH INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Clear Rayz for Him Stormy
    Primary DI
    00851478007196
    Version / Model
    DPA-021-Stormy
    Catalog Number
    DPA-021-Stormy
    Company Name
    QUASAR BIO-TECH INC.
    Labeler DUNS
    849862912
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-19
    Public Version
    4
    Public Version Date
    2020-07-07
    Public Version Status
    Update
    Public Device Record Key
    76fa81db-1a76-4820-a42f-ec565c686604

    Device Description

    No matter what your age, skin type, or skin tone, the blue and red lights treat and heal acne anywhere on your body..

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    OLP Over-The-Counter Powered Light Based Laser For Acne

    GMDN Terms

    Code Name
    62202 Blue/red/infrared phototherapy lamp

    Identifiers

    Type ID
    Primary 00851478007196

    Customer Contacts

    Phone
    941-306-5812
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K111286 000